Regemarine

Manufacturer: Zenith Medicosm SL
Effective date: 2012-01-21
Label type: HUMAN OTC DRUG LABEL
Version: 4
Source: full-release
Hydrated at: 2026-05-31 22:30:40

Label at a glance#

ProductRegemarine Extreme

Active ingredientOCTINOXATE

Label structure5 sections

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Octinoxate 7.5%

Description

DESCRIPTION SECTION

The exclusive formula with marine collagen, algae and rosehip oil regenerates damaged tissue and helps firm and hydrate skin. Specially designed for sagging and aged skin that requires progressive rejuvenation.

200ml. 6.8 Fl.Oz

Warning

WARNINGS SECTION

TOPICAL USE

PROFESSIONAL ONLY

Instruction for use:

INDICATIONS & USAGE SECTION

After applying COLLAGEN REGEMARINE EXTREME SERUM, rub the CREAM in gently until completely absorbed.

Instructions for use

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
42248-112-01	2019-11-13	C162847	48780-1	97449f38-cee1-f6ea-e053-dbdaa90aa703	Drug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
42248-112-01	RegemarineExtreme	200 mL in 1 TUBE	CREAM	200		4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
42248-112	REGEMARINE EXTREME (OCTINOXATE) CREAM [ZENITH MEDICOSM SL]	4	Legacy NDC, 1 package rows	20120123_b861c8ea-3206-4bf4-b210-7d1ee442456c.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	SPL version
OCTINOXATE	ACTIVE INGREDIENT	4Y5P7MUD51	4
OCTINOXATE	ACTIVE MOIETY	4Y5P7MUD51	4
ALLANTOIN	INACTIVE INGREDIENT	344S277G0Z	4
ALPHA-TOCOPHEROL ACETATE	INACTIVE INGREDIENT	9E8X80D2L0	4
BUTYLATED HYDROXYTOLUENE	INACTIVE INGREDIENT	1P9D0Z171K	4
CARBOMER 934	INACTIVE INGREDIENT	Z135WT9208	4
CETOSTEARYL ALCOHOL	INACTIVE INGREDIENT	2DMT128M1S	4
CHONDRUS CRISPUS	INACTIVE INGREDIENT	OQS23HUA1X	4
COLLAGEN, SOLUBLE, FISH SKIN	INACTIVE INGREDIENT	8JC99XGU4W	4
DIMETHICONE	INACTIVE INGREDIENT	92RU3N3Y1O	4
FUCUS VESICULOSUS	INACTIVE INGREDIENT	535G2ABX9M	4
ISOPROPYL PALMITATE	INACTIVE INGREDIENT	8CRQ2TH63M	4
MAGNESIUM ALUMINUM SILICATE	INACTIVE INGREDIENT	6M3P64V0NC	4
METHYLCHLOROISOTHIAZOLINONE	INACTIVE INGREDIENT	DEL7T5QRPN	4
METHYLISOTHIAZOLINONE	INACTIVE INGREDIENT	229D0E1QFA	4
METHYLPARABEN	INACTIVE INGREDIENT	A2I8C7HI9T	4
MINERAL OIL	INACTIVE INGREDIENT	T5L8T28FGP	4
PANAX GINSENG FRUIT	INACTIVE INGREDIENT	E35T4MOI3E	4
PEG-32 STEARATE	INACTIVE INGREDIENT	33GX5WQC0M	4
PEG-6 STEARATE	INACTIVE INGREDIENT	8LQC57C6B0	4
PEG-8 STEARATE	INACTIVE INGREDIENT	2P9L47VI5E	4
PEG/PPG-20/23 DIMETHICONE	INACTIVE INGREDIENT	XK68QT7HWY	4
PELVETIA CANALICULATA	INACTIVE INGREDIENT	8U1M44KESN	4
PROPYLENE GLYCOL	INACTIVE INGREDIENT	6DC9Q167V3	4
PROPYLPARABEN	INACTIVE INGREDIENT	Z8IX2SC1OH	4
ROSA MOSCHATA OIL	INACTIVE INGREDIENT	J99W255AWF	4
SOYBEAN	INACTIVE INGREDIENT	L7HT8F1ZOD	4
STEARIC ACID	INACTIVE INGREDIENT	4ELV7Z65AP	4
TROLAMINE	INACTIVE INGREDIENT	9O3K93S3TK	4
VITAMIN A PALMITATE	INACTIVE INGREDIENT	1D1K0N0VVC	4
WATER	INACTIVE INGREDIENT	059QF0KO0R	4
XANTHAN GUM	INACTIVE INGREDIENT	TTV12P4NEE	4

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 32 matching rows.

Regemarine Extreme
OCTINOXATE
MAGNESIUM ALUMINUM SILICATE
PROPYLPARABEN
ALPHA-TOCOPHEROL ACETATE
DIMETHICONE
XANTHAN GUM
ROSA MOSCHATA OIL
WATER
MINERAL OIL
CETOSTEARYL ALCOHOL
PEG-8 STEARATE
TROLAMINE
SOYBEAN
CHONDRUS CRISPUS
BUTYLATED HYDROXYTOLUENE
METHYLISOTHIAZOLINONE
CARBOMER 934
PROPYLENE GLYCOL
METHYLCHLOROISOTHIAZOLINONE
METHYLPARABEN
COLLAGEN, SOLUBLE, FISH SKIN
ISOPROPYL PALMITATE
PEG-6 STEARATE
PEG-32 STEARATE
STEARIC ACID
PANAX GINSENG FRUIT
PEG/PPG-20/23 DIMETHICONE
FUCUS VESICULOSUS
PELVETIA CANALICULATA
ALLANTOIN
VITAMIN A PALMITATE

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
42248-112	42248-112-01

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 31 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
MAGNESIUM ALUMINUM SILICATE	6M3P64V0NC	IACT
PROPYLPARABEN	Z8IX2SC1OH	IACT
ALPHA-TOCOPHEROL ACETATE	9E8X80D2L0	IACT
DIMETHICONE	92RU3N3Y1O	IACT
XANTHAN GUM	TTV12P4NEE	IACT
ROSA MOSCHATA OIL	J99W255AWF	IACT
WATER	059QF0KO0R	IACT
MINERAL OIL	T5L8T28FGP	IACT
CETOSTEARYL ALCOHOL	2DMT128M1S	IACT
PEG-8 STEARATE	2P9L47VI5E	IACT
TROLAMINE	9O3K93S3TK	IACT
SOYBEAN	L7HT8F1ZOD	IACT
CHONDRUS CRISPUS	OQS23HUA1X	IACT
BUTYLATED HYDROXYTOLUENE	1P9D0Z171K	IACT
METHYLISOTHIAZOLINONE	229D0E1QFA	IACT
CARBOMER 934	Z135WT9208	IACT
PROPYLENE GLYCOL	6DC9Q167V3	IACT
METHYLCHLOROISOTHIAZOLINONE	DEL7T5QRPN	IACT
METHYLPARABEN	A2I8C7HI9T	IACT
COLLAGEN, SOLUBLE, FISH SKIN	8JC99XGU4W	IACT
OCTINOXATE	4Y5P7MUD51	ACTIB
ISOPROPYL PALMITATE	8CRQ2TH63M	IACT
PEG-6 STEARATE	8LQC57C6B0	IACT
PEG-32 STEARATE	33GX5WQC0M	IACT
STEARIC ACID	4ELV7Z65AP	IACT
PANAX GINSENG FRUIT	E35T4MOI3E	IACT
PEG/PPG-20/23 DIMETHICONE	XK68QT7HWY	IACT
FUCUS VESICULOSUS	535G2ABX9M	IACT
PELVETIA CANALICULATA	8U1M44KESN	IACT
ALLANTOIN	344S277G0Z	IACT
VITAMIN A PALMITATE	1D1K0N0VVC	IACT

Source Document#

Source XML

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 8 · 426 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredient	IID ingredient	UNII	Dosage form / route	Potency	Maximum daily exposure	Match
BUTYLATED HYDROXYTOLUENE	BUTYLATED HYDROXYTOLUENE	1P9D0Z171K	SOAP / TOPICAL	0.02 %w/w		Exact identifier — unii candidate 32 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	CREAM, AUGMENTED / TOPICAL		2 mg	Exact identifier — unii candidate 79 equally ranked IID candidates
MAGNESIUM ALUMINUM SILICATE	MAGNESIUM ALUMINUM SILICATE	6M3P64V0NC	LOTION / TOPICAL	1.5 %w/w		Exact identifier — unii candidate 17 equally ranked IID candidates
BUTYLATED HYDROXYTOLUENE	BUTYLATED HYDROXYTOLUENE	1P9D0Z171K	INJECTION, SOLUTION / INTRAVENOUS	NA		Exact identifier — unii candidate 32 equally ranked IID candidates
MINERAL OIL	MINERAL OIL	T5L8T28FGP	TABLET, CHEWABLE / ORAL		6 mg	Exact identifier — unii candidate 30 equally ranked IID candidates
STEARIC ACID	STEARIC ACID	4ELV7Z65AP	TABLET / ORAL		336 mg	Exact identifier — unii candidate 26 equally ranked IID candidates
TROLAMINE	TROLAMINE	9O3K93S3TK	SOLUTION / NASAL	NA		Exact identifier — unii candidate 22 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	SOLUTION, CONCENTRATE / ORAL		2590 mg	Exact identifier — unii candidate 81 equally ranked IID candidates
SOYBEAN	SOYBEAN	L7HT8F1ZOD	EMULSION / TOPICAL	3 %w/w		Exact identifier — unii candidate 2 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	SHAMPOO / TOPICAL	0.15 %w/w		Exact identifier — unii candidate 79 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	GRANULE, FOR SUSPENSION / ORAL		80 mg	Exact identifier — unii candidate 79 equally ranked IID candidates
TROLAMINE	TROLAMINE	9O3K93S3TK	AEROSOL, FOAM / TOPICAL	2.6 %w/w		Exact identifier — unii candidate 22 equally ranked IID candidates
MINERAL OIL	MINERAL OIL	T5L8T28FGP	FILM, EXTENDED RELEASE / TRANSDERMAL	34 mg		Exact identifier — unii candidate 30 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	TABLET, FILM COATED / ORAL		96 mg	Exact identifier — unii candidate 81 equally ranked IID candidates
MINERAL OIL	MINERAL OIL	T5L8T28FGP	SYSTEM / TOPICAL	654.36 mg		Exact identifier — unii candidate 30 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	AEROSOL, FOAM / RECTAL		1214 mg	Exact identifier — unii candidate 81 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	TABLET, EXTENDED RELEASE / ORAL	9 mg		Exact identifier — unii candidate 81 equally ranked IID candidates
XANTHAN GUM	XANTHAN GUM	TTV12P4NEE	GRANULE, FOR SUSPENSION, EXTENDED RELEASE / ORAL		2350 mg	Exact identifier — unii candidate 29 equally ranked IID candidates
CARBOMER 934	CARBOMER HOMOPOLYMER TYPE B (ALLYL SUCROSE CROSSLINKED)	Z135WT9208	SUSPENSION/ DROPS / OPHTHALMIC	0.4 %w/v		Exact identifier — unii candidate 14 equally ranked IID candidates
PROPYLPARABEN	PROPYLPARABEN	Z8IX2SC1OH	GEL / VAGINAL		2 mg	Exact identifier — unii candidate 68 equally ranked IID candidates
STEARIC ACID	STEARIC ACID	4ELV7Z65AP	CREAM / TOPICAL		190 mg	Exact identifier — unii candidate 26 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	SOLUTION / TOPICAL		4886 mg	Exact identifier — unii candidate 81 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	SYRUP / ORAL		5700 mg	Exact identifier — unii candidate 81 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	FILM, EXTENDED RELEASE / TRANSDERMAL	58.13 mg		Exact identifier — unii candidate 81 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	CONCENTRATE / ORAL		7000 mg	Exact identifier — unii candidate 81 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	INJECTION / PERINEURAL		80 mg	Exact identifier — unii candidate 79 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	GEL / TOPICAL		4522 mg	Exact identifier — unii candidate 81 equally ranked IID candidates
MAGNESIUM ALUMINUM SILICATE	MAGNESIUM ALUMINUM SILICATE	6M3P64V0NC	LIQUID / ORAL	82 mg/5ml		Exact identifier — unii candidate 17 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	CAPSULE, EXTENDED RELEASE / ORAL		8 mg	Exact identifier — unii candidate 81 equally ranked IID candidates
MINERAL OIL	MINERAL OIL	T5L8T28FGP	SOAP / TOPICAL	0.82 %w/w		Exact identifier — unii candidate 30 equally ranked IID candidates
CARBOMER 934	CARBOMER HOMOPOLYMER TYPE B (ALLYL SUCROSE CROSSLINKED)	Z135WT9208	ENEMA / RECTAL	0.24 %w/v		Exact identifier — unii candidate 14 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	AEROSOL, FOAM / VAGINAL	0.1 %w/w		Exact identifier — unii candidate 79 equally ranked IID candidates
XANTHAN GUM	XANTHAN GUM	TTV12P4NEE	TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL		36 mg	Exact identifier — unii candidate 29 equally ranked IID candidates
ISOPROPYL PALMITATE	ISOPROPYL PALMITATE	8CRQ2TH63M	FILM, EXTENDED RELEASE / TRANSDERMAL	187.5 mg		Exact identifier — unii candidate 8 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	GEL / VAGINAL		750 mg	Exact identifier — unii candidate 81 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	EMULSION / TOPICAL	8 %w/w		Exact identifier — unii candidate 81 equally ranked IID candidates
PROPYLPARABEN	PROPYLPARABEN	Z8IX2SC1OH	INJECTION, POWDER, FOR SOLUTION / INTRAVENOUS	0.8 mg		Exact identifier — unii candidate 68 equally ranked IID candidates
XANTHAN GUM	XANTHAN GUM	TTV12P4NEE	PASTE / ORAL		1050 mg	Exact identifier — unii candidate 29 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	EMULSION / OPHTHALMIC	1.5 %w/v		Exact identifier — unii candidate 81 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	SOLUTION/ DROPS / OPHTHALMIC	0.75 %w/v		Exact identifier — unii candidate 81 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	SOLUTION / AURICULAR (OTIC)	56.55 %w/v		Exact identifier — unii candidate 81 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	SUSPENSION / OPHTHALMIC	0.6 %w/v		Exact identifier — unii candidate 81 equally ranked IID candidates
BUTYLATED HYDROXYTOLUENE	BUTYLATED HYDROXYTOLUENE	1P9D0Z171K	INJECTION, POWDER, FOR SOLUTION / INTRAVENOUS	NA		Exact identifier — unii candidate 32 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	SOLUTION / OPHTHALMIC	1 %w/v		Exact identifier — unii candidate 81 equally ranked IID candidates
BUTYLATED HYDROXYTOLUENE	BUTYLATED HYDROXYTOLUENE	1P9D0Z171K	OINTMENT / TOPICAL		57 mg	Exact identifier — unii candidate 32 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	SOLUTION / INTRAVENOUS	0.13 %w/v		Exact identifier — unii candidate 79 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	DROPS / NASAL	26 mg		Exact identifier — unii candidate 79 equally ranked IID candidates
PROPYLPARABEN	PROPYLPARABEN	Z8IX2SC1OH	INJECTION / INTRALESIONAL	0.02 %w/v		Exact identifier — unii candidate 68 equally ranked IID candidates
CARBOMER 934	CARBOMER HOMOPOLYMER TYPE B (ALLYL SUCROSE CROSSLINKED)	Z135WT9208	SUSPENSION / ORAL		288 mg	Exact identifier — unii candidate 14 equally ranked IID candidates
MINERAL OIL	MINERAL OIL	T5L8T28FGP	GEL / TOPICAL	2.5 %w/w		Exact identifier — unii candidate 30 equally ranked IID candidates
ALLANTOIN	ALLANTOIN	344S277G0Z	GEL / TOPICAL		8 mg	Exact identifier — unii candidate
STEARIC ACID	STEARIC ACID	4ELV7Z65AP	TABLET, FILM COATED, EXTENDED RELEASE / ORAL		120 mg	Exact identifier — unii candidate 26 equally ranked IID candidates
BUTYLATED HYDROXYTOLUENE	BUTYLATED HYDROXYTOLUENE	1P9D0Z171K	TABLET, EXTENDED RELEASE / ORAL		1 mg	Exact identifier — unii candidate 32 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	GEL / RECTAL		3315 mg	Exact identifier — unii candidate 81 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	INJECTION, POWDER, FOR SOLUTION / INTRAMUSCULAR	3.6 mg		Exact identifier — unii candidate 79 equally ranked IID candidates
PROPYLPARABEN	PROPYLPARABEN	Z8IX2SC1OH	SOLUTION / ORAL	100 mg		Exact identifier — unii candidate 68 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	SOLUTION / IONTOPHORESIS	0.1 %w/v		Exact identifier — unii candidate 79 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	TABLET, DELAYED RELEASE / ORAL		36 mg	Exact identifier — unii candidate 81 equally ranked IID candidates
MINERAL OIL	MINERAL OIL	T5L8T28FGP	TABLET, FILM COATED / ORAL	NA		Exact identifier — unii candidate 30 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	LOTION / TOPICAL		351 mg	Exact identifier — unii candidate 79 equally ranked IID candidates

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
2271626b-8be0-483f-a6a3-5b9f5176f40b			b861c8ea-3206-4bf4-b210-7d1ee442456c	2012-01-21	Warnings	Exact identifier spl id: 2271626b-8be0-483f-a6a3-5b9f5176f40b spl set id: b861c8ea-3206-4bf4-b210-7d1ee442456c

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.